Trials / Completed
CompletedNCT02212470
Drug Eluting Balloon Angioplasty Versus Nitinol Stent Implantation in the Superficial Femoral Artery
Randomized Controlled Trial of Paclitaxel Drug-coated Balloons vs. Nitinol Stent for Femoropopliteal Obstructions - The PAVENST Trial
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Instituto Dante Pazzanese de Cardiologia · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate whether the results of drug eluting balloon are non-inferior to the Nitinol stent implantation in the femoropopliteal segment.
Conditions
- Peripheral Arterial Disease
- Arterial Occlusive Diseases
- Atherosclerosis
- Arteriosclerosis
- Cardiovascular Diseases
- Peripheral Vascular Diseases
- Paclitaxel
- Plaque, Atherosclerotic
- Critical Limb Ischemia
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Drug Eluting Balloon Angioplasty | Angioplasty with Drug eluting balloon after pre dilatation |
| DEVICE | Nitinol stenting | Nitinol stent deployment |
Timeline
- Start date
- 2014-07-01
- Primary completion
- 2018-12-01
- Completion
- 2019-10-01
- First posted
- 2014-08-08
- Last updated
- 2021-06-10
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02212470. Inclusion in this directory is not an endorsement.